PADER - Pharmacovigilance software; Drug Safety Database

Need for this

Now-a-days Regulatory bodies like USFDA, EU strive to remain in competitive market, wants pharma companies to submit PADERs regularly to monitor the safety of marketed drugs as it mitigates risks and ensure patient safety. Hence the Intended practices for better stability in the market can direct impact on market and report submission performance.

Need to be versatile and concentrate on efficiency to maximize timeline, upcoming submission and report download.

Industries are adopting modern IT solutions to streamline, automate and simplify their processes to enhance productivity, efficiency, and quality.

How it Benefits

Increase Productivity

The system supports document creation, auto generate time consuming tasks, alert for upcoming submission, download all reports thus, improve productivity. Around 70% of workload and time will be reduced with PvEdge^® CDMS.

Reduce Operational Costs

With less manual work, companies can relocate resources to other critical areas, reducing the need for human errors. Decreases investigation time by viewing data reports.

Reduce Cost and Compliance

By ensuring timely and accurate submission PvEdge^® CDMS helps pharmaceutical companies comply with regulatory requirements. Automated process ensures that reports maintain high quality and consistency which is critical for regulatory compliance.

Efficiency Improvement

The system sends email reminder before 30days before submission date, ensuring all activities are tracked and completed on time. PvEdge^® CDMS can work as an individual system and to be integrated with other pharmacovigilance databases, providing flexibility and improving overall efficiency in data report management.

How We Are Using This in Existing Products

CDMS is designed as both separate module and integration with PvEdge^® relevant data and reports are automatically fetched from the pharmacovigilance database ensure all information is included in PADER. Users can create, edit and review documents directly with the system.

Result of Implementation of PADER

As a service recipient PADER software can streamline pharmacovigilance process, improve report quality by automated data integration and standardized data templates, enhance drug safety monitoring efforts by regular and timely submission, reduce workload by automating repetitive tasks and provide timely reminders, no chance of missing any timeliness.